Observational Study of Persons With Hepatitis B Virus Infection in North America

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- Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end stage liver disease and liver cancer. Although significant progress has been made recently in hepatitis B therapy, current knowledge about how to manage the infection is limited because most treatment trials involve 1 to 2 years of therapy at most, even though most patients require treatment of much longer duration for optimal long-term outcome. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B.

Objectives:

- To study individuals with hepatitis B and identify factors that affect the way the disease progresses.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with hepatitis B.

Design:

Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors, and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will provide biopsy material for further study.

Information will be collected during a series of study visits. Each visit will take approximately 1 hour. During the first year, participants will have study visits 12 weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years, participants will have a study visit approximately every 24 weeks (6 months) until the end of the study.

Additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study.

Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits.

Chronic hepatitis B virus infection is a leading cause of morbidity and mortality due to end stage liver disease and liver cancer. Although significant progress has been made in hepatitis B therapy, current knowledge about how to manage the infection is limited. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B.

The objectives of this study are to study individuals with acute and chronic hepatitis B to identify factors that affect disease progression. Individuals at least 18 years of age who have been diagnosed with hepatitis B will be eligible to participate. Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will be asked to provide biopsy material for further study. Information will be collected during a series of study visits, and additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study. Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits and may be eligible for treatment trials within the network.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 100 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

Written informed consent

At least 18 years of age

HBsAg-positive and either

Pregnant

Anti-HDV positive

Diagnosed with acute HBV infection or experiencing a hepatitis flare

Immune tolerant or immune active phenotype

Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study.